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To see the effect of drug Thalidomide in thalassemia

A prospective study to understand the clinical efficacy, safety, and molecular mechanisms of thalidomide-induced erythropoiesis in patients with non-transfusion dependent thalassemia (NTDT) - NA

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093906
Enrollment
194
Registered
2025-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

Interventions

Intervention1: Cap Thalidomide: Dose: [50 mg/day for adults and 2 mg/kg/day for children] with prospective increase to 100 mg/day for adults and 5 mg/kg/day for children. Duration: 12 months Control

Sponsors

ndian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed to have non-transfusion dependent thalassemia [NTDT] 2. Patients not on treatment/on treatment for less than 1 month 3. No major organ dysfunction [grade 3-4 heart, lungs, liver, kidneys]

Exclusion criteria

Exclusion criteria: 1. Diagnosis of thalassemia major 2. Patients on treatment for more than 1 month 3. Unwilling to sign consent

Design outcomes

Primary

MeasureTime frame
Improvement of hematological parameters and reducing transfusion frequency in patients with NTDT.Timepoint: Response assessments at 3,6 ,9 and 12 months of treatment

Secondary

MeasureTime frame
Identification of genetic markers that predict Thalidomide responsiveness in NTDT patients through comparative genomic analysis of responders and non-responders.Timepoint: Response assessments at 3,6 ,9 and 12 months of treatment

Countries

India

Contacts

Public ContactBiju George

Christian Medical College Vellore Ranipet campus,

biju@cmcvellore.ac.in04172224480

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026